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Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802864
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE January 4, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE February 4, 2019
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Pain scores 48 hours after surgery [ Time Frame: First 48 hours after surgery ]
Area under the curve of pain rankings on the 11-point numerical pain rating scales (0 indicating no pain and 10 indicating worst possible pain) assessed every 8 hours in the first 48 hours post-surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Pain scores 60 hours after surgery [ Time Frame: First 60 hours after surgery ]
    Area under the curve of pain rankings on the 11-point numerical pain rating scales (0 indicating no pain and 10 indicating worst possible pain) assessed twice daily in the first 60 hours post-surgery.
  • Pain scores 7 days after surgery [ Time Frame: First 7 days after surgery ]
    Area under the curve of pain rankings on the 11-point numerical pain rating scales (0 indicating no pain and 10 indicating worst possible pain) assessed twice daily in the first 7 days post-surgery.
  • Narcotic requirement [ Time Frame: First 7 days after surgery ]
    Total number of narcotic tablets required between the intervention and control arms during post-operative day 1 through 7.
  • Time to narcotic rescue [ Time Frame: First 7 days after surgery ]
    Time (in hours) to first rescue narcotic utilization between the two arms.
  • Pain control satisfaction [ Time Frame: 7th day after surgery ]
    Overall satisfaction of pain control regimen self reported on post-operative day 7. The prompt will be a yes/no answer. The percent of participants answering "yes" will be compared between the two arms.
  • Percentage of patients not requiring any narcotics [ Time Frame: 7th day after surgery ]
    The percentage of patients remaining opiate free by post-operative day 7.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Official Title  ICMJE Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Brief Summary The study is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study model is a randomized double blind control trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Male Infertility
Intervention  ICMJE
  • Drug: Liposomal Bupivacaine
    After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
  • Drug: Standard Bupivacaine
    After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
Study Arms  ICMJE
  • Experimental: Liposomal Bupivacaine
    Participants in this arm will have a single injection of liposomal bupivacaine admixed with standard bupivacaine (266mg liposomal bupivacaine mixed with 50mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
    Intervention: Drug: Liposomal Bupivacaine
  • Active Comparator: Standard Bupivacaine
    Participants in this arm will have a single injection of standard bupivacaine (100mg bupivacaine hydrochloride) at the conclusion of their surgical sperm retrieval procedure.
    Intervention: Drug: Standard Bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
85
Actual Study Completion Date  ICMJE January 30, 2020
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men scheduled for surgical sperm retrieval for infertility
  • Men 18 years and older who can provide informed consent
  • No documented allergy to bupivacaine or celecoxib

Exclusion Criteria:

  • Prior history of substance abuse
  • Any narcotic use within the last 3 months
  • Concomitant use of aspirin
  • Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
  • Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802864
Other Study ID Numbers  ICMJE 1802018993
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Pacira Pharmaceuticals, Inc
Investigators  ICMJE
Principal Investigator: Russell Hayden, MD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP